The Efficacy of Automated Feedback After Internet-based Depression Screening

Depression Clinical Trial

— DISCOVER  

Official title:

The Efficacy of Automated Feedback After Internet-based Depression Screening: the German, Three-armed, Randomised Controlled Trial DISCOVER

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633096
• Other study ID #: PV7039
• Status: Completed
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The DISCOVER randomized controlled trial is designed to evaluate the effect of automated feedback after internet-based depression screening in individuals with undetected depression. A total of 1076 individuals reporting elevated levels of depression (PHQ-9 score ≥ 10 points) will be randomized into three groups to either receive a) no feedback (control group), b) standardised or c) tailored feedback on their depression screening results.The primary hypothesis is that feedback reduces depression severity six months after screening compared to no feedback. The secondary hypothesis is that tailored feedback is more efficacious as compared to standard feedback.

Description:

Major depressive disorder (MDD) is a highly prevalent condition associated with substantial disease burden and economic costs. Still, it often remains undetected and untreated, which in turn increases the likelihood of a chronic course, treatment resistance and rising healthcare costs. One solution to address early detection and disease burden could be widely accessible depression screening. Our previous trial in cardiac patients provides first evidence that depression screening combined with written individual-targeted feedback on the screening results improves depression severity and encourages greater patient participation and engagement in mental health. To amplify these effects in a broader setting, the internet-based DISCOVER randomized controlled trial (RCT) now aims at addressing affected but yet undetected individuals on the internet. In order to evaluate the effect of feedback in this setting, a total of 1076 individuals reporting elevated levels of depression (PHQ-9 score ≥ 10) will be randomized into three groups. They either receive a) no feedback (control group), b) standardised or c) tailored feedback on their depression screening results. The primary hypothesis is that feedback reduces depression severity six months after screening compared to no feedback. The secondary hypothesis is that tailored feedback is more efficacious as compared to standard feedback. Futher outcomes are guideline-based depression care, depression-related help-seeking behaviour, a health economic evaluation, clinical outcomes (somatic symptom severity and anxiety), health-related quality of life, illness beliefs, intervention acceptance, depression diagnosis and adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1178
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• (Gender: male, female, diverse)
• Age = 18 years; no maximum age
• Sufficient German language skills
• Informed consent
• Patient Health Questionnaire-9 > 9 points
• Contact details
• Internet access
• Sufficient computer/internet literacy

Exclusion Criteria:

• Diagnosis of a depressive disorder within the past 12 months
• Depression treatment (current or within the past 12 months)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• tailored feedback of depression screening results
The feedback for the participant contains the screening result, information about depression in general, guideline based treatment recommendations for patients and contact-information for treatment. The information is tailored to the participant's individual symptom profile, illness perceptions and preferences.
• standardized feedback of depression screening results
The feedback for the participant contains the screening result, information about depression in general, guideline based treatment recommendations for patients and contact-information for treatment.

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Sikorski F, Konig HH, Wegscheider K, Zapf A, Lowe B, Kohlmann S. The efficacy of automated feedback after internet-based depression screening: Study protocol of the German, three-armed, randomised controlled trial DISCOVER. Internet Interv. 2021 Jul 21;25:100435. doi: 10.1016/j.invent.2021.100435. eCollection 2021 Sep. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Illness beliefs (Questionnaire: Brief-Illness Perception Questionnaire)	Depression-related illness beliefs assessed one and six months after screening with the Brief-Illness Perception Questionnaire. The Brief-Illness Perception Questionnaire includes 8 subscales (consequences, timeline, personal control, treatment control, illness comprehensibility, illness concern, illness-related emotions, causal attribution). Depending on each scale higher scores can represent functional or dysfunctional illness representations.	One and six months after screening
Other	Depression Diagnosis (Structured Clinical Interview for DSM-5 Disorders; depression-related module)	Proportion of individuals with a depression diagnosis as assessed with the Structured Clinical Interview for DSM-5 Disorders (depression-related module)	Two days and six months after screening
Other	Critical life events	Positive and negative critical life events, assessed by open questions six months after screening	Six months after screening
Other	Website use	Number of clicks per page	At baseline
Other	Intervention adherence	Extent to which participants have read the feedback (in percentage), as reported by participants six months after screening	Six months after screening
Primary	Depression severity (Questionnaire: Patient Health Questionnaire-9)	Level of depression severity assessed six months after screening with the Patient Health Questionnaire-9. Score range is 0 to 27 points. Higher scores mean more severe depression.	Six months after screening
Secondary	Depression severity (Questionnaire: Patient Health Questionnaire-9)	Level of depression severity assessed one month after screening with the Patient Health Questionnaire-9. Score range is 0 to 27 points. Higher scores mean more severe depression.	One month after screening
Secondary	Guideline-based depression care	Proportion of individuals treated according to German Guideline based recommendations (e.g. depression diagnosis by a health professional, psychotherapy)	Six months after screening
Secondary	Depression-related help-seeking behaviour	proportion of individuals seeking formal and informal help, including information seeking, self-help, online help, professional help.	Six months after screening
Secondary	Health economic Evaluation (Questionnaire: Client Sociodemographic and Service Receipt Inventory)	Health care use assessed six months after screening with the Client Sociodemographic and Service Receipt Inventory. The Client Sociodemographic and Service Receipt Inventory assesses health care use by assessing the use of healthcare services (e.g. hospital stays, health professional contacts), medication (e.g. type of drug) and work loss days (e.g. hospital days)	Six months after screening
Secondary	Health-related quality of life (Questionnaire: EuroQol-5D)	Health-related quality of life assessed six months after screening with the EuroQol-5D. The EuroQol-5D (EQ5D) consists of five items with a 4 point Likert scale reflecting five different dimensions of quality of life. Higher scores reflect better quality of life.	Six months after screening
Secondary	Anxiety (Questionnaire: Generalized Anxiety Disorder-7)	Level of anxiety assessed six months after screening with the Generalized Anxiety Disorder-7. Score range is 0 to 21 points. Higher scores mean more anxiety.	Six months after screening
Secondary	Somatic symptom severity (Questionnaire: Somatic Symptom Scale-8)	Level of somatic symptom severity assessed six months after screening with the Somatic Symptom Scale.8. Score range is 0 to 32 points. Higher scores mean more somatic symptom burden.	Six months after screening
Secondary	Intervention acceptance (Questionnaire: Usefulness scale for patient information material)	Usefulness and satisfaction with the feedback intervention material will be assessed one month after screening with the Usefulness Scale for patient information material. Score range is 0 to 100 points. Higher scores mean better usefulness. Items are added to assess PHQ-9-based depression screening.	One month after screening
Secondary	Adverse events	Proportion of individuals reporting the occurence of any negative event that is attributed to the trial assessed by one open question six months after screening	Six months after screening

External Links

•   Study protocoll